Many persons who have acquired the habit of smoking tobacco are desirous of quitting. However, the addicting effects of tobacco smoking make it difficult for smokers to quit. Further, tobacco smoke is known to have deleterious effects to a person's teeth, gums and periodontal areas such as discoloration and gingivitis.
The health hazards from tobacco smoking are well established. Of the approximately 4,000 by-products of combustion found in cigarette smoke, many of which are known carcinogens, the three substances studied most have been tars, carbon monoxide and nicotine. Tars and carbon monoxide have been directly implicated in the production or exacerbation of numerous health disorders.
Thus, tars are the causative agents in cigarette smoke most implicated in the induction of cancers such as lung, larynx, oral cavity, esophageal, bladder, kidney, pancreatic, stomach and uterine and cervix cancers. Tars are also considered responsible for the induction of the hepatic microsomal enzyme systems which result in more rapid deactivation of a variety of drugs such as benzodiazepines as well as anti-depressants and analgesics. Tars are also responsible for the production of bronco pulmonary diseases, including pulmonary emphysema, chronic bronchitis, and smokers respiratory syndrome.
Carbon monoxide, a deadly gas, is an important health hazard even in minute quantities because it combines with the hemoglobin in the blood so that the hemoglobin can no longer carry sufficient oxygen. Moreover, the stimulant effect of the nicotine in the smoke causes an increase in cardiac workload and oxygen demand, whereas the carbon monoxide effectly blocks the ability of the heart muscle to capture the needed oxygen. In other words, carbon monoxide and nicotine work together in a synergistically negative manner in a way which often results in muscular hypoxia or anoxia and ultimately in cardiac damage. In addition, carbon monoxide has also been implicated as a causative agent in the development of such disorders as coronary artery disease and atherosclerosis.
Nicotine appears to be the most pharmacologically active substance in tobacco smoke, yet it appears to be not as significant from a health standpoint as the tars and carbon monoxide. However, nicotine is very important from another standpoint, i.e. it is the reinforcing substance in tobacco smoke which initiates and maintains the addiction. In this respect, a theme commonly heard among workers in the field of smoking research is: "People would be disinclined to smoke cigarettes if an alternate route of nicotine delivery could be devised."
Several such attempts have been made to administer nicotine in alternate ways, but with varying and generally ineffective results. For example, nicotine-containing pills have been studied; however, effective blood levels of nicotine are not achieved because drugs absorbed in the stomach pass through the liver first where, in this case, 80-90 percent of nicotine deactivation occurs. Similar findings have been demonstrated with nicotine chewing gum although it has been sufficiently successful to warrant its marketing.
There are other long established and traditional ways of absorbing nicotine through the mouth, including chewing tobacco, snuff and products which constitute diffusion bags of tobacco, all of such means relying on oral (or nasal) absorption of nicotine through the mucous membrane. However, because of the taste and other sensory effects of tobacco, such a manner of satisfying the nicotine habit is acceptable to only a very limited number of persons. Moreover, these habits still require the utilization of tobacco, and such use remains a problem especially for people with gum, mouth or throat problems as a result of long-term tobacco chewing or snuff "dipping" and who are unable to quit.
With regard to the nicotine gum referred to above, it has produced mouth ulcers in a number of individuals resulting in its rejection. In addition, the nicotine gum produces some gastric absorption with the resultant first pass through the liver and consequent rapid loss of activity. Moreover, people with artificial teeth have difficulty with gum in general; this is important as many people who experience the medical problems associated with years of smoking also tend to have generally poor dental hygiene and/or dental quality, and may also have artificial teeth.
Nicotine itself has been subjected to considerable study. Nicotine is a liquid alkaloid which is colorless, volatile and strongly alkaline. On exposure to air it turns brown. It is known to be very lipid soluble. The Merck Index, 9th Edition, 1976, page 847, indicates that nicotine base is readily absorbed through mucous membrane and intact skin, but the salts are not. On the other hand, nicotine has no known therapeutic application (The Pharmacological Basis of Therapeutics, fifth edition, Goodman and Gilman, 1970, page 588) and has been primarily used in research as an experimental tool for investigating neural function.
It is known in the art to incorporate nicotine into lozenges and chewing gum so as to provide for a means of dispensing nicotine into a person's system so as to overcome the urge to smoke. However, such chewing gums and lozenges, such as described in published French Patent Application No. 2 608 156 can cause nausea in the person using such gums and/or lozenges due to the ingestion of nicotine into the stomach and other portions of the digestive tract.
It has been proposed that a nicotine-containing lozenge be compounded with lactose (or a lactose-containing substance) a known antidote to nicotine poisoning and the unpleasant nausea and discomforts associated with nicotine ingestion, such as described in published European Patent Application No. 0 251 642.
However, in all cases of nicotine-containing lozenges and/or chewing gums, it is believed that a large portion of the nicotine is not effectively absorbed into the blood stream, thereby reducing to a certain degree the beneficial effect of smoking urge suppression sought to be achieved. At the same time, the necessary carriers in lozenges and chewing gums, i.e. those comprised of sugars and like substances, have a tendency to promote dental decay in the nature of dental caries, particularly in the interproximal surfaces of the teeth.
In Etscorn, U.S. Pat. No. 4,597,961, there is described a method of transcutaneous application of nicotine through the use of an occlusive pad so that the nicotine is administered transdermally. The occlusive pad described therein is intended solely for external application.
None of the foregoing patents mention or suggest the application of nicotine to dental floss, nor the use of such nicotine-containing dental floss in the suppression of the urge to smoke.
Flossing of the teeth is known in the art to help remove plaque from the tooth surface. Further, it is known in the art to apply dentrifice medicaments to dental floss.
For example, Lynch, U.S. Pat. Nos. 4,632,937 and 4,627,975 discloses coating dental floss with a solution of a dentrifice formulation containing monoalkyl and dialkyl ethers of dianhydrohexitols, which is said to be effective in the treatment of oral surfaces and cavities to reduce irritation and plaque accumulation caused by the action of bacteria.
Similarly, Newman et al., U.S. Pat. No. 4,548,219, disclose a fluoride-coated dental floss which has bactericidal activity; and Tarrson et al., U.S. Pat. No. 4,162,688, disclose fluoride medicated dental floss and a dispenser for the wet application of fluoride to floss.
Cousse et al., U.S. Pat. No. 4,098,879, disclose impregnating dental floss with fluoride salts of certain pyridine compounds, alone or in combination with ethyl-3-nicotinate hydrofluoride or Vitamin B, as inhibiting dental plaque.
However, none of the prior art relating to dental floss describe treating the floss with nicotine and the advantages of employing dental floss in aiding individuals to quit smoking.
Surprisingly, applicant has found that by providing a nicotine-treated dental floss there is provided an article of manufacture which produces both a beneficial periodontal effect and aids in alleviating an individual's urge to engage in tobacco smoking.